—#93248

Product

Boston Scientific Ultraflex Covered large Esophageal Stent System - Distal Release (23/28/10/7) Material/UPN/Catalog Number: M00514200

FDA product code: ESW — Prosthesis, Esophageal
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K091816
Affected lot / code info: Lot/Batch Number: 13436624

Why it was recalled

Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.

Root cause (FDA determination)

Process control

Action the firm took

Boston Scientific issued "Urgent Medical Device Recall - Immediate Action Required" letters dated July 15,2010 to consignees. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Foreign accounts received notification translated into the local language and with changes that are applicable to local regulations. Boston Scientific can be contacted at 1-508-683-4427.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden

Timeline

Recall initiated: 2010-07-15
Posted by FDA: 2010-08-31
Terminated: 2011-10-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93248. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.